Medical devices containing animal tissue of Transmissible Spongiform Encephalopathy (TSE) prone species (cow, sheep, goat, deer, elk, mink, and cat) or material derived from such tissue are subject to the requirements of both directives and conformance to the following standards must be demonstrated:

Without an EDQM (European Directorate for the Quality of Medicines and Healthcare) certificate for the animal tissue or substance, we are also obliged to enter a consultation process with the EC Competent Authorities on the risk/benefit of using the animal tissue or derivative in this device.

Medical devices containing such material are considered by the Competent Authorities in Europe as automatically being of the highest risk. To achieve certification which includes the animal tissue directive it is important to work with an audit partner such as SGS who is experienced in animal tissue assessments and can advise you on the documentation required to demonstrate a positive benefit-to-risk ratio. Our global network of offices ensures that wherever your operation is based, certification can be achieved.